Training to Reconnect With Emotional Awareness Therapy

NCT ID: NCT03414463

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-08
• Study Completion Date: 2023-11-14

Brief Summary

To decrease emotional self-awareness deficits and improve emotional self-regulation, particularly anxiety, anger, depression, and positive affect, through the treatment of alexithymia.

Detailed Description

Phase II randomized, Waitlist Control (WLC) trial with 3-month follow-up to further establish proof of concept and early efficacy of TREAT (1:1 alexithymia treatment) for post-TBI alexithymia. It is anticipated that our target sample size is 44. The purpose of this study is to examine differences in post-treatment self-reported alexithymia and emotional self-awareness in participants with TBI randomized to TREAT or WLC. In addition to examining the differences in post-treatment self-reported emotion regulation (general), anxiety, anger, depression, positive affect (PA), global emotional function and quality of life in participants with TBI randomized to TREAT or WLC.

Conditions

Traumatic Brain Injury; Alexithymia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TREAT

A 4-week one-to-one intervention between the clinical RA (cRA) and participant. Comprised of eight sessions, it involves psycho-educational lessons and skill-building exercises to achieve objectives based on the characteristics of alexithymia.

Group Type: EXPERIMENTAL

TREAT

Intervention Type: BEHAVIORAL

A 4-week one-to-one intervention between the clinical RA (cRA) and participant. Comprised of eight sessions, it involves psycho-educational lessons and skill-building exercises to achieve objectives based on the characteristics of alexithymia.

Waitlist Control

After Time 1 testing in Week 1, participants randomized to WLC will not receive any treatment during Weeks 2-5. The only staff interaction during this no treatment time period will be to schedule Time 2 testing appointment for week 6. After Time 2 testing, WLC will receive TREAT (weeks 14-17), followed up with testing.

Group Type: EXPERIMENTAL

TREAT

Intervention Type: BEHAVIORAL

A 4-week one-to-one intervention between the clinical RA (cRA) and participant. Comprised of eight sessions, it involves psycho-educational lessons and skill-building exercises to achieve objectives based on the characteristics of alexithymia.

Interventions

TREAT

A 4-week one-to-one intervention between the clinical RA (cRA) and participant. Comprised of eight sessions, it involves psycho-educational lessons and skill-building exercises to achieve objectives based on the characteristics of alexithymia.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• TBI (injury due to a external physical force)
• Complicated mild, moderate, or severe TBI (defined by Glasgow Coma Scale (GCS) in Emergency Department (ED) (≤12), or Post traumatic amnesia (PTA) (≥1 day),Loss of Conscientious (LOC) (≥30 minutes),or positive head CT scan consistent with TBI)
• At least 18 years or older
• ≥1 year post-injury
• Adequate vision, hearing, speech, and comprehension
• Reliable mode of transportation
• Available for treatment during regular business hours
• Have moderate to high screening alexithymia score (TAS-20 ≥52)
• If participating in active psychological treatment prior to enrollment, their participation must be ongoing for 4 or more weeks

Exclusion Criteria

• Diagnosed with pre-morbid neurological disorder that could affect mood and cognition (e.g., stroke, Alzheimer's disease, Parkinson's disease); does not include controlled seizures
• Diagnosed with major psychiatric disorder (e.g., schizophrenia, Borderline Personality Disorder)
• Severe Depression and/or perceived risk to self or others
• Developmental disability (e.g. autism, developmental delay)
• Unstable or anticipated medication changes related to mood or emotion during study participation
• Having started psychological treatment less than 4 weeks prior to enrollment
• Actively participating in the Traumatic Brain Injury Model System (TBIMS) alexithymia outcome module

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Flora Hammond

Chair of Department of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flora Hammond, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

1711946589

Identifier Type: -

Identifier Source: org_study_id